Deep Brain Stimulation (DBS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)
NCT ID: NCT04217408
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
10 participants
INTERVENTIONAL
2019-09-01
2024-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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ON stimulation followed by OFF stimulation
All patients complete the same 52 week open-label phase with active stimulation. After this, they enter a blinded randomized crossover phase of 2 weeks of ON (active) stimulation, followed by 2 weeks of OFF (sham) stimulation
Deep brain stimulation
Active continuous deep brain stimulation of the ventral capsule/ventral striatum
OFF stimulation followed by ON stimulation
All patients complete the same 52 week open-label phase with active stimulation. After this, they enter a blinded randomized crossover phase of 2 weeks of OFF (sham) stimulation, followed by 2 weeks of ON (active) stimulation
Deep brain stimulation
Active continuous deep brain stimulation of the ventral capsule/ventral striatum
Interventions
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Deep brain stimulation
Active continuous deep brain stimulation of the ventral capsule/ventral striatum
Eligibility Criteria
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Inclusion Criteria
2. DSM-V diagnosis of Obsessive Compulsive Disorder (OCD), at least 5-year illness history with a minimum score of 24 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
3. SF-36\<40
4. Medication-refractoriness as determined by an adequate dose and duration of psychiatric treatments (including psychotherapy and/or pharmacology) as determined by two psychiatrists associated with the study. Including specifically:
1. Failed adequate trial of two or more medications accepted as first line in the treatment of OCD
2. Attempted augmentation, if tolerated, by at least 1 medications known to be first line treatments for OCD
5. An adequate trial of cognitive behavioural therapy
6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols
Exclusion Criteria
2. Active neurologic disease, such as epilepsy
3. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
4. Current suicidal ideation
5. Any contraindication to MRI scanning
6. No contraindication for DBS surgery
7. Presence of significant cognitive impairment
8. Likely to relocate or move out of the country during the study's duration
9. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
10. Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
18 Years
70 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Nir Lipsman
Dr Nir Lipsman, MD, PhD, Neurosurgeon, Scientist
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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111-2018
Identifier Type: -
Identifier Source: org_study_id